Indications Treatment of severe recalcitrant cystic acne.

Treatment of keratinization disorders, cutaneous T-cell lymphoma, leukoplakia; prevention of skin cancer in patients with xeroderma pigmentosum.

 Contraindications Hypersensitivity to parabens; pregnancy.

 Route/Dosage

Adults: PO 0.5 to 2 mg/kg/day divided into 2 doses for 15 to 20 wk.

 Interactions

Vitamin A: May increase toxic effects; do not take with isotretinoin. Tetracycline/Minocycline: Have been associated with pseudotumor cerebri or papilledema in isotretinoin patients. Carbamazepine: Coadministration has resulted in reduced carbamazepine plasma level. Drug/Food interactions: When taken with food, the absorption of isotretinoin has increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Transient chest pain; vasculitis. CNS: Fatigue; headache; pseudotumor cerebri (eg, benign intracranial hypertension with headache, visual disturbances, and papilledema). DERMATOLOGIC: Cheilitis; skin fragility; dry skin; pruritus; facial skin desquamation; dry mucous membranes; nail brittleness; rash; thinning of hair; skin infections; photosensitivity; palmoplantar desquamation; exaggerated healing response manifested by exuberant granulation tissue with crusting; pyogenic granuloma; petechiae; bruising. EENT: Conjunctivitis; corneal opacities; cataracts; visual disturbances; dry eyes; contact lens intolerance; decreased night vision; epistaxis; dry nose; impaired hearing. GI: Dry mouth; nausea; vomiting; abdominal pain; nonspecific GI symptoms; anorexia; inflammatory bowel disease. GU: WBC cells in urine; proteinuria; microscopic or gross hematuria; nonspecific urogenital findings. HEMATOLOGIC: Anemia; decreased RBC parameters and WBC counts; elevated platelet counts; elevated sedimentation rate. HEPATIC: Elevated liver enzymes; hepatitis. METABOLIC: Increased fasting serum glucose; hyperuricemia; elevated CPK levels after exercise. OTHER: Arthralgia; bone, joint, and muscle pain and stiffness; flushing; reversibly elevated triglycerides; increased cholesterol level.

 Precautions

Pregnancy: Category X. There is an extremely high risk of deformity to the infant if pregnancy occurs while taking this drug in any amount, even for short periods. Potentially, all exposed fetuses can be affected. Presently, there are no accurate means of determining after isotretinoin exposure which fetus has or has not been affected. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Acne: Transient exacerbation of acne may occur, generally during initial therapy period. Childbearing potential: Isotretinoin is contraindicated in women of childbearing potential unless all conditions of the consent form included with the product information are met. See product information and Patient Information leaflet. Inflammatory bowel disease: Inflammatory bowel disease, including regional ileitis, has been temporally associated with isotretinoin use. Musculoskeletal effects: Decreases in lumbar spine and total hip bone mineral density have been observed. Osteoporosis, osteopenia, bone fracture, and delayed healing of bone fractures as well as premature epiphyseal closure have been seen in patients receiving isotretinoin. Pancreatitis: Acute pancreatitis has been reported with elevated or normal serum triglyceride levels. In rare cases, fatal hemorrhagic pancreatitis has been reported. Psychiatric disorders: May cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide. Photosensitivity: May occur; avoid excessive sunlight and ultraviolet light.

 Administration/Storage

• Instruct patient to swallow capsules whole. Do not open or crush capsules.
• Give medication with meals.
• Second course of therapy may be initiated if needed after 2 mo off therapy.
• Store in tightly closed, light-resistant container at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to parabens.
• Obtain baseline lipid levels and then monitor q 2 wk for first month and then monitor monthly.
• Obtain LFTs at 2- to 3-wk intervals for first 6 mo and then every month throughout course of therapy.
• In diabetic patients, monitor glucose levels carefully.
• If increased triglyceride levels occur, discontinue drug immediately.
• Notify health care provider of signs and symptoms of decreased liver function (eg, dark urine, jaundice, pruritus), visual disturbances, nausea, vomiting, and headache.

 Patient/Family Education

• Because of teratogenic effects, instruct patient to practice abstinence or use 2 reliable methods of birth control during therapy and for 1 mo before and after therapy.
• Advise patient to be seen by health care provider monthy and have a urine or serum pregnancy test performed each month to confirm negative pregnancy status.
• Instruct patient to notify health care provider immediately if pregnancy is suspected.
• Advise patient to take medication with meals.
• Instruct patient to discontinue any other acne medications (including OTC topical preparations) before starting therapy.
• Advise patient to control weight, decrease dietary fat, and restrict alcohol intake 36 hr before lipid determinations to avoid elevation in serum triglycerides.
• Caution patient against use of vitamin A, even in multivitamins, to avoid additive toxicity.
• Inform patient that contact lens tolerance may decrease.
• Suggest use of lubricant (eg, petroleum jelly) on lips to prevent cheilitis.
• Advise patient not to donate blood for at least 30 days after discontinuing therapy.
• Inform patient that transient exacerbations of acne may be experienced during first few weeks of therapy. Advise patient to continue drug therapy because this may be normal response.
• Caution patient that decreased night vision can occur and onset can be sudden. Advise patient to be cautious when driving or operating any vehicle at night.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reactions.
• Caution patient that problems could arise in the control of blood sugar.
• Inform patient of availability of Patient Information leaflet, emphasizing the need to carefully review pregnancy warnings and fetal risks.
• Prior to use, have patient complete a consent form included with package insert.
• Instruct patient to immediately notify health care provider if any of the following symptoms occur: depression, visual disturbances, abdominal pain, rectal bleeding, severe diarrhea, difficulty in controlling blood sugar, decreased tolerance to contact lens.
• Inform patient to avoid wax epilation and skin resurfacing procedures (eg, dermabrasion, laser) during therapy and for at least 6 mo thereafter because of possible scarring.

Indications for Drugs ::

 Action Reduces sebum secretion and sebaceous gland size, inhibits sebaceous gland differentiation, and alters sebum lipid composition.

 Indications Treatment of severe recalcitrant cystic acne.

Treatment of keratinization disorders, cutaneous T-cell lymphoma, leukoplakia; prevention of skin cancer in patients with xeroderma pigmentosum.

 Contraindications Hypersensitivity to parabens; pregnancy.

 Route/Dosage

Adults: PO 0.5 to 2 mg/kg/day divided into 2 doses for 15 to 20 wk.

 Interactions

Vitamin A: May increase toxic effects; do not take with isotretinoin. Tetracycline/Minocycline: Have been associated with pseudotumor cerebri or papilledema in isotretinoin patients. Carbamazepine: Coadministration has resulted in reduced carbamazepine plasma level. Drug/Food interactions: When taken with food, the absorption of isotretinoin has increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Transient chest pain; vasculitis. CNS: Fatigue; headache; pseudotumor cerebri (eg, benign intracranial hypertension with headache, visual disturbances, and papilledema). DERMATOLOGIC: Cheilitis; skin fragility; dry skin; pruritus; facial skin desquamation; dry mucous membranes; nail brittleness; rash; thinning of hair; skin infections; photosensitivity; palmoplantar desquamation; exaggerated healing response manifested by exuberant granulation tissue with crusting; pyogenic granuloma; petechiae; bruising. EENT: Conjunctivitis; corneal opacities; cataracts; visual disturbances; dry eyes; contact lens intolerance; decreased night vision; epistaxis; dry nose; impaired hearing. GI: Dry mouth; nausea; vomiting; abdominal pain; nonspecific GI symptoms; anorexia; inflammatory bowel disease. GU: WBC cells in urine; proteinuria; microscopic or gross hematuria; nonspecific urogenital findings. HEMATOLOGIC: Anemia; decreased RBC parameters and WBC counts; elevated platelet counts; elevated sedimentation rate. HEPATIC: Elevated liver enzymes; hepatitis. METABOLIC: Increased fasting serum glucose; hyperuricemia; elevated CPK levels after exercise. OTHER: Arthralgia; bone, joint, and muscle pain and stiffness; flushing; reversibly elevated triglycerides; increased cholesterol level.

 Precautions

Pregnancy: Category X. There is an extremely high risk of deformity to the infant if pregnancy occurs while taking this drug in any amount, even for short periods. Potentially, all exposed fetuses can be affected. Presently, there are no accurate means of determining after isotretinoin exposure which fetus has or has not been affected. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Acne: Transient exacerbation of acne may occur, generally during initial therapy period. Childbearing potential: Isotretinoin is contraindicated in women of childbearing potential unless all conditions of the consent form included with the product information are met. See product information and Patient Information leaflet. Inflammatory bowel disease: Inflammatory bowel disease, including regional ileitis, has been temporally associated with isotretinoin use. Musculoskeletal effects: Decreases in lumbar spine and total hip bone mineral density have been observed. Osteoporosis, osteopenia, bone fracture, and delayed healing of bone fractures as well as premature epiphyseal closure have been seen in patients receiving isotretinoin. Pancreatitis: Acute pancreatitis has been reported with elevated or normal serum triglyceride levels. In rare cases, fatal hemorrhagic pancreatitis has been reported. Psychiatric disorders: May cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide. Photosensitivity: May occur; avoid excessive sunlight and ultraviolet light.

 Administration/Storage

• Instruct patient to swallow capsules whole. Do not open or crush capsules.
• Give medication with meals.
• Second course of therapy may be initiated if needed after 2 mo off therapy.
• Store in tightly closed, light-resistant container at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to parabens.
• Obtain baseline lipid levels and then monitor q 2 wk for first month and then monitor monthly.
• Obtain LFTs at 2- to 3-wk intervals for first 6 mo and then every month throughout course of therapy.
• In diabetic patients, monitor glucose levels carefully.
• If increased triglyceride levels occur, discontinue drug immediately.
• Notify health care provider of signs and symptoms of decreased liver function (eg, dark urine, jaundice, pruritus), visual disturbances, nausea, vomiting, and headache.

 Patient/Family Education

• Because of teratogenic effects, instruct patient to practice abstinence or use 2 reliable methods of birth control during therapy and for 1 mo before and after therapy.
• Advise patient to be seen by health care provider monthy and have a urine or serum pregnancy test performed each month to confirm negative pregnancy status.
• Instruct patient to notify health care provider immediately if pregnancy is suspected.
• Advise patient to take medication with meals.
• Instruct patient to discontinue any other acne medications (including OTC topical preparations) before starting therapy.
• Advise patient to control weight, decrease dietary fat, and restrict alcohol intake 36 hr before lipid determinations to avoid elevation in serum triglycerides.
• Caution patient against use of vitamin A, even in multivitamins, to avoid additive toxicity.
• Inform patient that contact lens tolerance may decrease.
• Suggest use of lubricant (eg, petroleum jelly) on lips to prevent cheilitis.
• Advise patient not to donate blood for at least 30 days after discontinuing therapy.
• Inform patient that transient exacerbations of acne may be experienced during first few weeks of therapy. Advise patient to continue drug therapy because this may be normal response.
• Caution patient that decreased night vision can occur and onset can be sudden. Advise patient to be cautious when driving or operating any vehicle at night.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reactions.
• Caution patient that problems could arise in the control of blood sugar.
• Inform patient of availability of Patient Information leaflet, emphasizing the need to carefully review pregnancy warnings and fetal risks.
• Prior to use, have patient complete a consent form included with package insert.
• Instruct patient to immediately notify health care provider if any of the following symptoms occur: depression, visual disturbances, abdominal pain, rectal bleeding, severe diarrhea, difficulty in controlling blood sugar, decreased tolerance to contact lens.
• Inform patient to avoid wax epilation and skin resurfacing procedures (eg, dermabrasion, laser) during therapy and for at least 6 mo thereafter because of possible scarring.

Drug Dose ::

 Action Reduces sebum secretion and sebaceous gland size, inhibits sebaceous gland differentiation, and alters sebum lipid composition.

 Indications Treatment of severe recalcitrant cystic acne.

Treatment of keratinization disorders, cutaneous T-cell lymphoma, leukoplakia; prevention of skin cancer in patients with xeroderma pigmentosum.

 Contraindications Hypersensitivity to parabens; pregnancy.

 Route/Dosage

Adults: PO 0.5 to 2 mg/kg/day divided into 2 doses for 15 to 20 wk.

 Interactions

Vitamin A: May increase toxic effects; do not take with isotretinoin. Tetracycline/Minocycline: Have been associated with pseudotumor cerebri or papilledema in isotretinoin patients. Carbamazepine: Coadministration has resulted in reduced carbamazepine plasma level. Drug/Food interactions: When taken with food, the absorption of isotretinoin has increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Transient chest pain; vasculitis. CNS: Fatigue; headache; pseudotumor cerebri (eg, benign intracranial hypertension with headache, visual disturbances, and papilledema). DERMATOLOGIC: Cheilitis; skin fragility; dry skin; pruritus; facial skin desquamation; dry mucous membranes; nail brittleness; rash; thinning of hair; skin infections; photosensitivity; palmoplantar desquamation; exaggerated healing response manifested by exuberant granulation tissue with crusting; pyogenic granuloma; petechiae; bruising. EENT: Conjunctivitis; corneal opacities; cataracts; visual disturbances; dry eyes; contact lens intolerance; decreased night vision; epistaxis; dry nose; impaired hearing. GI: Dry mouth; nausea; vomiting; abdominal pain; nonspecific GI symptoms; anorexia; inflammatory bowel disease. GU: WBC cells in urine; proteinuria; microscopic or gross hematuria; nonspecific urogenital findings. HEMATOLOGIC: Anemia; decreased RBC parameters and WBC counts; elevated platelet counts; elevated sedimentation rate. HEPATIC: Elevated liver enzymes; hepatitis. METABOLIC: Increased fasting serum glucose; hyperuricemia; elevated CPK levels after exercise. OTHER: Arthralgia; bone, joint, and muscle pain and stiffness; flushing; reversibly elevated triglycerides; increased cholesterol level.

 Precautions

Pregnancy: Category X. There is an extremely high risk of deformity to the infant if pregnancy occurs while taking this drug in any amount, even for short periods. Potentially, all exposed fetuses can be affected. Presently, there are no accurate means of determining after isotretinoin exposure which fetus has or has not been affected. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Acne: Transient exacerbation of acne may occur, generally during initial therapy period. Childbearing potential: Isotretinoin is contraindicated in women of childbearing potential unless all conditions of the consent form included with the product information are met. See product information and Patient Information leaflet. Inflammatory bowel disease: Inflammatory bowel disease, including regional ileitis, has been temporally associated with isotretinoin use. Musculoskeletal effects: Decreases in lumbar spine and total hip bone mineral density have been observed. Osteoporosis, osteopenia, bone fracture, and delayed healing of bone fractures as well as premature epiphyseal closure have been seen in patients receiving isotretinoin. Pancreatitis: Acute pancreatitis has been reported with elevated or normal serum triglyceride levels. In rare cases, fatal hemorrhagic pancreatitis has been reported. Psychiatric disorders: May cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide. Photosensitivity: May occur; avoid excessive sunlight and ultraviolet light.

 Administration/Storage

• Instruct patient to swallow capsules whole. Do not open or crush capsules.
• Give medication with meals.
• Second course of therapy may be initiated if needed after 2 mo off therapy.
• Store in tightly closed, light-resistant container at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to parabens.
• Obtain baseline lipid levels and then monitor q 2 wk for first month and then monitor monthly.
• Obtain LFTs at 2- to 3-wk intervals for first 6 mo and then every month throughout course of therapy.
• In diabetic patients, monitor glucose levels carefully.
• If increased triglyceride levels occur, discontinue drug immediately.
• Notify health care provider of signs and symptoms of decreased liver function (eg, dark urine, jaundice, pruritus), visual disturbances, nausea, vomiting, and headache.

 Patient/Family Education

• Because of teratogenic effects, instruct patient to practice abstinence or use 2 reliable methods of birth control during therapy and for 1 mo before and after therapy.
• Advise patient to be seen by health care provider monthy and have a urine or serum pregnancy test performed each month to confirm negative pregnancy status.
• Instruct patient to notify health care provider immediately if pregnancy is suspected.
• Advise patient to take medication with meals.
• Instruct patient to discontinue any other acne medications (including OTC topical preparations) before starting therapy.
• Advise patient to control weight, decrease dietary fat, and restrict alcohol intake 36 hr before lipid determinations to avoid elevation in serum triglycerides.
• Caution patient against use of vitamin A, even in multivitamins, to avoid additive toxicity.
• Inform patient that contact lens tolerance may decrease.
• Suggest use of lubricant (eg, petroleum jelly) on lips to prevent cheilitis.
• Advise patient not to donate blood for at least 30 days after discontinuing therapy.
• Inform patient that transient exacerbations of acne may be experienced during first few weeks of therapy. Advise patient to continue drug therapy because this may be normal response.
• Caution patient that decreased night vision can occur and onset can be sudden. Advise patient to be cautious when driving or operating any vehicle at night.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reactions.
• Caution patient that problems could arise in the control of blood sugar.
• Inform patient of availability of Patient Information leaflet, emphasizing the need to carefully review pregnancy warnings and fetal risks.
• Prior to use, have patient complete a consent form included with package insert.
• Instruct patient to immediately notify health care provider if any of the following symptoms occur: depression, visual disturbances, abdominal pain, rectal bleeding, severe diarrhea, difficulty in controlling blood sugar, decreased tolerance to contact lens.
• Inform patient to avoid wax epilation and skin resurfacing procedures (eg, dermabrasion, laser) during therapy and for at least 6 mo thereafter because of possible scarring.

Contraindication ::

 Action Reduces sebum secretion and sebaceous gland size, inhibits sebaceous gland differentiation, and alters sebum lipid composition.

 Indications Treatment of severe recalcitrant cystic acne.

Treatment of keratinization disorders, cutaneous T-cell lymphoma, leukoplakia; prevention of skin cancer in patients with xeroderma pigmentosum.

 Contraindications Hypersensitivity to parabens; pregnancy.

 Route/Dosage

Adults: PO 0.5 to 2 mg/kg/day divided into 2 doses for 15 to 20 wk.

 Interactions

Vitamin A: May increase toxic effects; do not take with isotretinoin. Tetracycline/Minocycline: Have been associated with pseudotumor cerebri or papilledema in isotretinoin patients. Carbamazepine: Coadministration has resulted in reduced carbamazepine plasma level. Drug/Food interactions: When taken with food, the absorption of isotretinoin has increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Transient chest pain; vasculitis. CNS: Fatigue; headache; pseudotumor cerebri (eg, benign intracranial hypertension with headache, visual disturbances, and papilledema). DERMATOLOGIC: Cheilitis; skin fragility; dry skin; pruritus; facial skin desquamation; dry mucous membranes; nail brittleness; rash; thinning of hair; skin infections; photosensitivity; palmoplantar desquamation; exaggerated healing response manifested by exuberant granulation tissue with crusting; pyogenic granuloma; petechiae; bruising. EENT: Conjunctivitis; corneal opacities; cataracts; visual disturbances; dry eyes; contact lens intolerance; decreased night vision; epistaxis; dry nose; impaired hearing. GI: Dry mouth; nausea; vomiting; abdominal pain; nonspecific GI symptoms; anorexia; inflammatory bowel disease. GU: WBC cells in urine; proteinuria; microscopic or gross hematuria; nonspecific urogenital findings. HEMATOLOGIC: Anemia; decreased RBC parameters and WBC counts; elevated platelet counts; elevated sedimentation rate. HEPATIC: Elevated liver enzymes; hepatitis. METABOLIC: Increased fasting serum glucose; hyperuricemia; elevated CPK levels after exercise. OTHER: Arthralgia; bone, joint, and muscle pain and stiffness; flushing; reversibly elevated triglycerides; increased cholesterol level.

 Precautions

Pregnancy: Category X. There is an extremely high risk of deformity to the infant if pregnancy occurs while taking this drug in any amount, even for short periods. Potentially, all exposed fetuses can be affected. Presently, there are no accurate means of determining after isotretinoin exposure which fetus has or has not been affected. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Acne: Transient exacerbation of acne may occur, generally during initial therapy period. Childbearing potential: Isotretinoin is contraindicated in women of childbearing potential unless all conditions of the consent form included with the product information are met. See product information and Patient Information leaflet. Inflammatory bowel disease: Inflammatory bowel disease, including regional ileitis, has been temporally associated with isotretinoin use. Musculoskeletal effects: Decreases in lumbar spine and total hip bone mineral density have been observed. Osteoporosis, osteopenia, bone fracture, and delayed healing of bone fractures as well as premature epiphyseal closure have been seen in patients receiving isotretinoin. Pancreatitis: Acute pancreatitis has been reported with elevated or normal serum triglyceride levels. In rare cases, fatal hemorrhagic pancreatitis has been reported. Psychiatric disorders: May cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide. Photosensitivity: May occur; avoid excessive sunlight and ultraviolet light.

 Administration/Storage

• Instruct patient to swallow capsules whole. Do not open or crush capsules.
• Give medication with meals.
• Second course of therapy may be initiated if needed after 2 mo off therapy.
• Store in tightly closed, light-resistant container at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to parabens.
• Obtain baseline lipid levels and then monitor q 2 wk for first month and then monitor monthly.
• Obtain LFTs at 2- to 3-wk intervals for first 6 mo and then every month throughout course of therapy.
• In diabetic patients, monitor glucose levels carefully.
• If increased triglyceride levels occur, discontinue drug immediately.
• Notify health care provider of signs and symptoms of decreased liver function (eg, dark urine, jaundice, pruritus), visual disturbances, nausea, vomiting, and headache.

 Patient/Family Education

• Because of teratogenic effects, instruct patient to practice abstinence or use 2 reliable methods of birth control during therapy and for 1 mo before and after therapy.
• Advise patient to be seen by health care provider monthy and have a urine or serum pregnancy test performed each month to confirm negative pregnancy status.
• Instruct patient to notify health care provider immediately if pregnancy is suspected.
• Advise patient to take medication with meals.
• Instruct patient to discontinue any other acne medications (including OTC topical preparations) before starting therapy.
• Advise patient to control weight, decrease dietary fat, and restrict alcohol intake 36 hr before lipid determinations to avoid elevation in serum triglycerides.
• Caution patient against use of vitamin A, even in multivitamins, to avoid additive toxicity.
• Inform patient that contact lens tolerance may decrease.
• Suggest use of lubricant (eg, petroleum jelly) on lips to prevent cheilitis.
• Advise patient not to donate blood for at least 30 days after discontinuing therapy.
• Inform patient that transient exacerbations of acne may be experienced during first few weeks of therapy. Advise patient to continue drug therapy because this may be normal response.
• Caution patient that decreased night vision can occur and onset can be sudden. Advise patient to be cautious when driving or operating any vehicle at night.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reactions.
• Caution patient that problems could arise in the control of blood sugar.
• Inform patient of availability of Patient Information leaflet, emphasizing the need to carefully review pregnancy warnings and fetal risks.
• Prior to use, have patient complete a consent form included with package insert.
• Instruct patient to immediately notify health care provider if any of the following symptoms occur: depression, visual disturbances, abdominal pain, rectal bleeding, severe diarrhea, difficulty in controlling blood sugar, decreased tolerance to contact lens.
• Inform patient to avoid wax epilation and skin resurfacing procedures (eg, dermabrasion, laser) during therapy and for at least 6 mo thereafter because of possible scarring.

Drug Precautions ::

 Action Reduces sebum secretion and sebaceous gland size, inhibits sebaceous gland differentiation, and alters sebum lipid composition.

 Indications Treatment of severe recalcitrant cystic acne.

Treatment of keratinization disorders, cutaneous T-cell lymphoma, leukoplakia; prevention of skin cancer in patients with xeroderma pigmentosum.

 Contraindications Hypersensitivity to parabens; pregnancy.

 Route/Dosage

Adults: PO 0.5 to 2 mg/kg/day divided into 2 doses for 15 to 20 wk.

 Interactions

Vitamin A: May increase toxic effects; do not take with isotretinoin. Tetracycline/Minocycline: Have been associated with pseudotumor cerebri or papilledema in isotretinoin patients. Carbamazepine: Coadministration has resulted in reduced carbamazepine plasma level. Drug/Food interactions: When taken with food, the absorption of isotretinoin has increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Transient chest pain; vasculitis. CNS: Fatigue; headache; pseudotumor cerebri (eg, benign intracranial hypertension with headache, visual disturbances, and papilledema). DERMATOLOGIC: Cheilitis; skin fragility; dry skin; pruritus; facial skin desquamation; dry mucous membranes; nail brittleness; rash; thinning of hair; skin infections; photosensitivity; palmoplantar desquamation; exaggerated healing response manifested by exuberant granulation tissue with crusting; pyogenic granuloma; petechiae; bruising. EENT: Conjunctivitis; corneal opacities; cataracts; visual disturbances; dry eyes; contact lens intolerance; decreased night vision; epistaxis; dry nose; impaired hearing. GI: Dry mouth; nausea; vomiting; abdominal pain; nonspecific GI symptoms; anorexia; inflammatory bowel disease. GU: WBC cells in urine; proteinuria; microscopic or gross hematuria; nonspecific urogenital findings. HEMATOLOGIC: Anemia; decreased RBC parameters and WBC counts; elevated platelet counts; elevated sedimentation rate. HEPATIC: Elevated liver enzymes; hepatitis. METABOLIC: Increased fasting serum glucose; hyperuricemia; elevated CPK levels after exercise. OTHER: Arthralgia; bone, joint, and muscle pain and stiffness; flushing; reversibly elevated triglycerides; increased cholesterol level.

 Precautions

Pregnancy: Category X. There is an extremely high risk of deformity to the infant if pregnancy occurs while taking this drug in any amount, even for short periods. Potentially, all exposed fetuses can be affected. Presently, there are no accurate means of determining after isotretinoin exposure which fetus has or has not been affected. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Acne: Transient exacerbation of acne may occur, generally during initial therapy period. Childbearing potential: Isotretinoin is contraindicated in women of childbearing potential unless all conditions of the consent form included with the product information are met. See product information and Patient Information leaflet. Inflammatory bowel disease: Inflammatory bowel disease, including regional ileitis, has been temporally associated with isotretinoin use. Musculoskeletal effects: Decreases in lumbar spine and total hip bone mineral density have been observed. Osteoporosis, osteopenia, bone fracture, and delayed healing of bone fractures as well as premature epiphyseal closure have been seen in patients receiving isotretinoin. Pancreatitis: Acute pancreatitis has been reported with elevated or normal serum triglyceride levels. In rare cases, fatal hemorrhagic pancreatitis has been reported. Psychiatric disorders: May cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide. Photosensitivity: May occur; avoid excessive sunlight and ultraviolet light.

 Administration/Storage

• Instruct patient to swallow capsules whole. Do not open or crush capsules.
• Give medication with meals.
• Second course of therapy may be initiated if needed after 2 mo off therapy.
• Store in tightly closed, light-resistant container at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to parabens.
• Obtain baseline lipid levels and then monitor q 2 wk for first month and then monitor monthly.
• Obtain LFTs at 2- to 3-wk intervals for first 6 mo and then every month throughout course of therapy.
• In diabetic patients, monitor glucose levels carefully.
• If increased triglyceride levels occur, discontinue drug immediately.
• Notify health care provider of signs and symptoms of decreased liver function (eg, dark urine, jaundice, pruritus), visual disturbances, nausea, vomiting, and headache.

 Patient/Family Education

• Because of teratogenic effects, instruct patient to practice abstinence or use 2 reliable methods of birth control during therapy and for 1 mo before and after therapy.
• Advise patient to be seen by health care provider monthy and have a urine or serum pregnancy test performed each month to confirm negative pregnancy status.
• Instruct patient to notify health care provider immediately if pregnancy is suspected.
• Advise patient to take medication with meals.
• Instruct patient to discontinue any other acne medications (including OTC topical preparations) before starting therapy.
• Advise patient to control weight, decrease dietary fat, and restrict alcohol intake 36 hr before lipid determinations to avoid elevation in serum triglycerides.
• Caution patient against use of vitamin A, even in multivitamins, to avoid additive toxicity.
• Inform patient that contact lens tolerance may decrease.
• Suggest use of lubricant (eg, petroleum jelly) on lips to prevent cheilitis.
• Advise patient not to donate blood for at least 30 days after discontinuing therapy.
• Inform patient that transient exacerbations of acne may be experienced during first few weeks of therapy. Advise patient to continue drug therapy because this may be normal response.
• Caution patient that decreased night vision can occur and onset can be sudden. Advise patient to be cautious when driving or operating any vehicle at night.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reactions.
• Caution patient that problems could arise in the control of blood sugar.
• Inform patient of availability of Patient Information leaflet, emphasizing the need to carefully review pregnancy warnings and fetal risks.
• Prior to use, have patient complete a consent form included with package insert.
• Instruct patient to immediately notify health care provider if any of the following symptoms occur: depression, visual disturbances, abdominal pain, rectal bleeding, severe diarrhea, difficulty in controlling blood sugar, decreased tolerance to contact lens.
• Inform patient to avoid wax epilation and skin resurfacing procedures (eg, dermabrasion, laser) during therapy and for at least 6 mo thereafter because of possible scarring.

Drug Side Effects ::

 Action Reduces sebum secretion and sebaceous gland size, inhibits sebaceous gland differentiation, and alters sebum lipid composition.

 Indications Treatment of severe recalcitrant cystic acne.

Treatment of keratinization disorders, cutaneous T-cell lymphoma, leukoplakia; prevention of skin cancer in patients with xeroderma pigmentosum.

 Contraindications Hypersensitivity to parabens; pregnancy.

 Route/Dosage

Adults: PO 0.5 to 2 mg/kg/day divided into 2 doses for 15 to 20 wk.

 Interactions

Vitamin A: May increase toxic effects; do not take with isotretinoin. Tetracycline/Minocycline: Have been associated with pseudotumor cerebri or papilledema in isotretinoin patients. Carbamazepine: Coadministration has resulted in reduced carbamazepine plasma level. Drug/Food interactions: When taken with food, the absorption of isotretinoin has increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Transient chest pain; vasculitis. CNS: Fatigue; headache; pseudotumor cerebri (eg, benign intracranial hypertension with headache, visual disturbances, and papilledema). DERMATOLOGIC: Cheilitis; skin fragility; dry skin; pruritus; facial skin desquamation; dry mucous membranes; nail brittleness; rash; thinning of hair; skin infections; photosensitivity; palmoplantar desquamation; exaggerated healing response manifested by exuberant granulation tissue with crusting; pyogenic granuloma; petechiae; bruising. EENT: Conjunctivitis; corneal opacities; cataracts; visual disturbances; dry eyes; contact lens intolerance; decreased night vision; epistaxis; dry nose; impaired hearing. GI: Dry mouth; nausea; vomiting; abdominal pain; nonspecific GI symptoms; anorexia; inflammatory bowel disease. GU: WBC cells in urine; proteinuria; microscopic or gross hematuria; nonspecific urogenital findings. HEMATOLOGIC: Anemia; decreased RBC parameters and WBC counts; elevated platelet counts; elevated sedimentation rate. HEPATIC: Elevated liver enzymes; hepatitis. METABOLIC: Increased fasting serum glucose; hyperuricemia; elevated CPK levels after exercise. OTHER: Arthralgia; bone, joint, and muscle pain and stiffness; flushing; reversibly elevated triglycerides; increased cholesterol level.

 Precautions

Pregnancy: Category X. There is an extremely high risk of deformity to the infant if pregnancy occurs while taking this drug in any amount, even for short periods. Potentially, all exposed fetuses can be affected. Presently, there are no accurate means of determining after isotretinoin exposure which fetus has or has not been affected. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Acne: Transient exacerbation of acne may occur, generally during initial therapy period. Childbearing potential: Isotretinoin is contraindicated in women of childbearing potential unless all conditions of the consent form included with the product information are met. See product information and Patient Information leaflet. Inflammatory bowel disease: Inflammatory bowel disease, including regional ileitis, has been temporally associated with isotretinoin use. Musculoskeletal effects: Decreases in lumbar spine and total hip bone mineral density have been observed. Osteoporosis, osteopenia, bone fracture, and delayed healing of bone fractures as well as premature epiphyseal closure have been seen in patients receiving isotretinoin. Pancreatitis: Acute pancreatitis has been reported with elevated or normal serum triglyceride levels. In rare cases, fatal hemorrhagic pancreatitis has been reported. Psychiatric disorders: May cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide. Photosensitivity: May occur; avoid excessive sunlight and ultraviolet light.

 Administration/Storage

• Instruct patient to swallow capsules whole. Do not open or crush capsules.
• Give medication with meals.
• Second course of therapy may be initiated if needed after 2 mo off therapy.
• Store in tightly closed, light-resistant container at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to parabens.
• Obtain baseline lipid levels and then monitor q 2 wk for first month and then monitor monthly.
• Obtain LFTs at 2- to 3-wk intervals for first 6 mo and then every month throughout course of therapy.
• In diabetic patients, monitor glucose levels carefully.
• If increased triglyceride levels occur, discontinue drug immediately.
• Notify health care provider of signs and symptoms of decreased liver function (eg, dark urine, jaundice, pruritus), visual disturbances, nausea, vomiting, and headache.

 Patient/Family Education

• Because of teratogenic effects, instruct patient to practice abstinence or use 2 reliable methods of birth control during therapy and for 1 mo before and after therapy.
• Advise patient to be seen by health care provider monthy and have a urine or serum pregnancy test performed each month to confirm negative pregnancy status.
• Instruct patient to notify health care provider immediately if pregnancy is suspected.
• Advise patient to take medication with meals.
• Instruct patient to discontinue any other acne medications (including OTC topical preparations) before starting therapy.
• Advise patient to control weight, decrease dietary fat, and restrict alcohol intake 36 hr before lipid determinations to avoid elevation in serum triglycerides.
• Caution patient against use of vitamin A, even in multivitamins, to avoid additive toxicity.
• Inform patient that contact lens tolerance may decrease.
• Suggest use of lubricant (eg, petroleum jelly) on lips to prevent cheilitis.
• Advise patient not to donate blood for at least 30 days after discontinuing therapy.
• Inform patient that transient exacerbations of acne may be experienced during first few weeks of therapy. Advise patient to continue drug therapy because this may be normal response.
• Caution patient that decreased night vision can occur and onset can be sudden. Advise patient to be cautious when driving or operating any vehicle at night.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reactions.
• Caution patient that problems could arise in the control of blood sugar.
• Inform patient of availability of Patient Information leaflet, emphasizing the need to carefully review pregnancy warnings and fetal risks.
• Prior to use, have patient complete a consent form included with package insert.
• Instruct patient to immediately notify health care provider if any of the following symptoms occur: depression, visual disturbances, abdominal pain, rectal bleeding, severe diarrhea, difficulty in controlling blood sugar, decreased tolerance to contact lens.
• Inform patient to avoid wax epilation and skin resurfacing procedures (eg, dermabrasion, laser) during therapy and for at least 6 mo thereafter because of possible scarring.

Drug Mode of Action ::  

 Action Reduces sebum secretion and sebaceous gland size, inhibits sebaceous gland differentiation, and alters sebum lipid composition.